Blood collection apparatus

ABSTRACT

An apparatus for collecting blood from a patient, comprising a collection vessel having a pleated, compressible body, the vessel having an inlet port adapted to be connected to a patient line for drawing blood from a patient; at least one, each outlet port adapted to be connected to a blood collection bag.

[0001] The present invention relates to an apparatus for collectingblood from a patient, and, in particular, apparatus for use inautologous blood transfusion. The apparatus may also be used for wounddrainage.

[0002] During surgery, blood is drawn from the operation site of thepatient.

[0003] In some cases, the blood needs to be removed from the site toallow the site to be clearly seen and accessed during the operation.Also, during and after the operation, the wound needs to drained ofblood.

[0004] The patient may bleed profusely during and after an operationand, after such blood loss, will need to undergo a blood transfusion.Known ways of providing blood transfusions are Homologous BloodTransfusion in which blood is collected from donors other than therecipient (often referred to as Allogenic transfusions), and AutologousBlood Transfusion, wherein blood is collected from the patient duringthe operation or shortly after the operation and the same blood,collected from the patient, is then reinfused into the patient.

[0005] There are a number of risks associated with Homologous Bloodtransfusion. Infectious agents, e.g. hepatitis, CJD, HIV,Cytomegalovirus and other viruses, can be transmitted from the donors tothe patient.

[0006] Transfusion of blood from another can cause non-haemolyticfebrile transfusion reactions. Other associated risks are those ofalloimmunisation, post transfusion thrombocytopenia, firbonectindepletion, histamine release and transfusion induced immunosuppression.Autologous Blood Transfusion, in contrast, has a number of advantages.As the patient's own blood is used, there is a huge saving on donatedblood of which more is then available for other applications. There isan improved postoperative response and the risks of infection,transfusion reaction and alloimmunisation are substantially reduced.

[0007] Furthermore, Autologous Blood Transfusion is much cheaper thanHomologous Blood Transfusion and also much more convenient.

[0008] Autologous Blood Transfusion has, therefore, become extremelypopular and is particularly useful in orthopedic surgery, spinalsurgery, vascular surgery, cardio-vascular surgery and liver surgery.

[0009] Thus, there is a need in this field for suitable apparatus forcollecting the blood from the patient.

[0010] Two main types of blood collection or blood drainage apparatusare known in the art. One of these is a flask type collection system,wherein blood is drawn from the patient by suction into a rigidcollection flask. A blood collection bag is attached to an outlet portof the collection flask by means of a connector arrangement such as aclamp and push fit connector, a clamp in combination with a continuousline to the blood bag, or an open-and-close valve. The clamp andcontinuous line is used to allow re-infusion to the patient (the line isvery long) whilst the flask continues to collect. This has benefits forJehovah's witnesses. Once the required amount of blood has beencollected in the flask, the valve is opened and the blood is droppeddown into the bag which is then sealed.

[0011] The bag is marked with identification data of the patient etc.and the blood may then be either disposed of, stored or used forautologous blood transfusion.

[0012] Another type of wound drainage blood collection system is in theform of a plastic bellows type collection chamber. Before collection,the bellows is primed by compressing the chamber. Blood is thencollected under the vacuum formed by the bellows, along the patient lineconnected to the input of bellows chamber. Again, a blood collection bagis collected to the output of the blood collection chamber by means of avalve. With the bellows type system, blood is continually passed throughthe chamber into the bag, during collection. Again, the bag is thenremoved and the blood is either disposed of, or used for autologousblood transfusion.

[0013] Generally, in wound drainage systems, the solid flask typearrangements provide a high vacuum and are used, therefore, to drawblood from less sensitive wound regions. In more sensitive regions, e.g.in areas around sensitive nerves, the lower vacuum bellows type systemis used. Below is a table showing various types of surgery for whichhigh and/or low vacuum drainage is suitable. High Vacuum Low VacuumOrthopaedics Knee Yes Yes Hip Yes Yes Spine Yes Yes General MastectomyYes Yes Axillary Lymph No Yes Abdomina No Yes Tumour Yes No Arterial NoYes Hernia Yes Yes Gynaecology Vagina Plastics No Yes Cystocele Yes -only 150 ml version No Caesarean No Yes ORL Surgery Thyroidectomy No YesParotidectomy Yes No Laryngectomy Yes No Plastic Surgery Hand Yes YesFace Lift Yes No Breast Yes No Urology Nephroctomy No Yes CardioVascular Plexus No Yes Trepanation No Yes Cervical HNP No Yes Sub duralHaematoma No Yes Intra cranial No Yes Dental Jaws Yes No Teeth Root YesNo

[0014] Similarly, in autologous blood transfusion systems, the blood iscollected, generally, by means of either a flask collection systems or abellows collection system at low level vacuum.

[0015] As in autologous blood transfusion, the blood is reused byreinfusion into the patient, there are, naturally, very stringentcriteria as to the conditions under which the blood is collected,including the types of material used, the operating conditions, pressureapplied, time over which the blood is collected, etc.

[0016] For example, the maximum pressure under which the blood should becollected is 100 mmHg. Pressures higher than this damage the blood cellsand this means that the blood can no longer be reinfused into thepatient.

[0017] The regulations require that in autologous blood transfusion, themaximum permissibly blood collection time is six hours. If bloodcontinues to be collected in the flask beyond that period, the bloodcells can deteriorate (since the age of the blood affects its ability toperform) and the blood cannot be reused by reinfusion. Research showsthat, generally, 500 to 700 ml of blood are collected in any six-hourperiod. At the end of this period, the bag must be sealed and the bloodreinfused into the patient.

[0018] However, during certain operations, for example during kneeoperations, the patient loses around 1 litre of blood and there is,therefore, a need to keep collecting blood from the wound or operationsite beyond this six-hour period.

[0019] The blood to be collected after the six-hour period can becollected in a second bag but, unless the conditions are completelysterile, on attachment of the second bag, this second lot of blood isnot suitable for reinfusion and must be disposed of. This blood is,therefore, wasted.

[0020] As mentioned above, there are, essentially, two standard types ofproduct currently in use for blood collection, particularly forautologous blood transfusion.

[0021] One of these is a rigid flask type system manufactured by DuxburyScientific and described in, for example, U.S. Pat. No. 5,628,726.

[0022] Another flask type collection apparatus is manufactured byStryker Corp. and is described, for example, in U.S. Pat. No. 5,830,198,and 5,645,540.

[0023] With the flask type arrangements, which comprise a rigid plasticflask having an inlet port and an outlet port, a vacuum is applied tothe flask, via a vacuum port. Blood is then drawn from the patient,along the patient line, connected to the input of the flask. The bloodis drawn into the flask, through a filter, and collects in the flask.The outlet port, which is connected to a blood collection bag, is thenopened and the blood which is collected in the flask is ‘dumped down’into the bag, for retransfusion or disposal.

[0024] The flask arrangements provide a continuous constant vacuum whichmeans that they can be used inter-operatively, as well aspost-operatively.

[0025] As discussed above, it is only permissible to collect blood in ablood collection bag over a maximum period of six hours.

[0026] If more blood is to be collected, this needs to be collected in asecond bag.

[0027] To simplify this, Duxbury Scientific have produced a flask systemcalled Betatrans®. The Betatrans® has two outlet ports, each having afilter sock, connected to the port inside of the collection flask, andan open-and-close valve at the outlet side, to which a blood collectionbag is connected.

[0028] For the first collection period, up to six hours, blood iscollected in the flask and dropped down into one of the bags, while thevalve to the other bag is kept closed. At the end of that bloodcollection period, either when the bag is full or when the six-hourperiod has expired, the valve to first bag is closed and the bag isremoved. The further blood is then collected in the second bag.

[0029] Although the connector valves on the Betatrans® product, forconnecting the blood bags, are relatively simple, they involve aclick-type fit arrangement which is different from the previously andcommonly used push-fit connectors.

[0030] Research has shown that these new valve connectors have not beenconsidered as a benefit with operation room personnel, who are used tousing the standard push-fit connectors, and they have not been adoptedfor use, widely.

[0031] Furthermore, the flask type systems are relatively cumbersome andexpensive. Also, if the flask is tilted, during use, the ports canbecome blocked and, therefore, anti-tilt mechanisms have been provided.

[0032] Another problem is that, as described above, in the flaskarrangement, the blood is first collected in the flask and then thevalve between the flask and the collection bag is opened when the bloodis “dumped down” from the flask into the bag. A filter sock is providedat the output port to filter the blood before it is dumped down into thebag.

[0033] However, because the blood is collected in the flask, and thereis a relatively large contact area between the blood and the flask, fora relatively long period of time, the blood sees the contact with theflask as contact with a foreign body and blood clotting can result. Eventhough filters are provided, blood clotting can still result at theoutput ports, and block the ports.

[0034] One attempted solution has been to provide a filter sock in theinput to the flask which filters incoming blood instead of outgoingblood. However, the problem of the large surface area of contact withthe plastic flask still exists and clots can still form.

[0035] A second type of blood collection system uses a bellows typearrangement similar to those discussed above in relation to wounddrainage. One such system is the Astra Tech Bellovac™ system.

[0036] In this system, a catheter is placed in situ and connected to theinlet tubing. To evacuate blood from the operation area, an inlet clampis closed, the bellows are compressed and the inlet clamp is reopened.This procedure is repeated until the blood starts to flow or the bellowsremain compressed. The clamps are then closed and the device is thusprimed. The blood collection bag is attached to the outlet port of thebellows and is marked with the identity of the patient, the timecollection started and the time (maximum six hours) when collectionshould be terminated. The device is then hung in an appropriateposition, using the bag rail strap. The extension line is connectedbetween the bag and the outlet port of the bellows before collection. Toempty the contents of the bellows into the collection bag, the inletclamp is closed and the outlet clamp is opened. The bellows are thencompressed slowly, using the palm of the hand, and the liquid istransferred into the bag. The outlet clamp is then closed and the inletclamp opened to continue drainage.

[0037] Such systems are much preferred by nursing stuff, as they arerelatively light, simple to use and use simple push-fit connectors atthe inputs and outputs.

[0038] One feature of the bellows arrangement is that the vacuum is notconstant and, therefore, such collection systems can only be usedpost-operatively, and not intra-operatively. However, these relativelylow vacuum systems can be used in more sensitive areas. The bellows typesystem is much simpler, lighter and less expensive than the flasksystem, this latter factor being important in the field of disposabledevices.

[0039] The bellows system is also more accepted by operating roompersonnel, as they are used to using such systems, as they are used insuch systems in general low vacuum wound drainage. Again, this is animportant factor in surgical apparatus, where familiarity with theoperation of the devices is crucial.

[0040] Another advantage is that the blood passes continuously throughthe bellows vacuum chamber into the collection bag and thus remains lessin contact with the plastic interior surface of the collection chamber.Thus, the risk of clotting is reduced substantially.

[0041] A further advantage is that if the bellows device is tilted orlaid on a bed, as often happens in practice, there is no flow-backbecause there is no wall suction and, also, the one-way valve within theinlet line/bellows stops any flow-back.

[0042] As mentioned above, regulations state that blood for reinfusionmust be collected within a period of no more than six hours. In manyoperations, however, blood needs to continue to be collected beyond sixhours and, to optimise the use of this blood in autologous bloodtransfusion, it is useful if a new blood collection bag can be attachedand a new collection started.

[0043] With the known systems, however, once the first bag is removed,because the bag is full or because the six-hour collection period hasexpired, a second bag can be attached to the output port, but that portmay well be contaminated due to exposure to air during the exchange ofthe bag. Also, during exchange, when the blood becomes exposed to air,the blood remaining in the valve connector part may clot.

[0044] Thus, although a new bag may be attached to the connector port tocollect the remaining blood from the patient, that blood is not ofsufficient quality, or the quality cannot be guaranteed, such that theblood can be reinfused. The system can, then, only be used as a wounddrainage system and the blood collected in the second bag must bedisposed of.

[0045] There is thus a need for an autologous blood transfusioncollection system which optimises the collection of usable blood, inaccordance with all of the regulations, ensuring that all safetycriteria are met, whilst providing a system which is simple, easy to useand inexpensive.

[0046] Accordingly, in one aspect, the present invention provides ablood collection apparatus, comprising a collection vessel having apleated, compressible body, the vessel having an inlet port adapted tobe connected to a patient line for drawing blood from a patient; twooutlet ports, each outlet port adapted to be connected to a bloodcollection bag.

[0047] The input and output ports are preferably adapted to be connectedto the patient line and the bags, respectively, by means of a push fitconnection.

[0048] The ports are all preferably provided with closure means tooptionally prevent flow through the ports.

[0049] Preferably, there is provided a one-way valve at or before theinlet port and at or connected, in use, to the outlet ports to preventflow-back of the blood.

[0050] In accordance with another aspect, the invention provides a bloodcollection apparatus comprising a blood collection vessel having apleated, compressible body, an inlet port and an outlet port; where theinlet port comprises two port connections, the first adapted to beconnected to a patient line through which blood is collected from thepatient, and the second being adapted to be attached to a constantvacuum.

[0051] The apparatus of the first aspect of the invention may beprovided with an inlet port as described in the second aspect of theinvention.

[0052] Preferred embodiments of the invention will now be described, byway of example only, with reference to the accompanying drawings.

[0053]FIG. 1 shows a schematic view of the components of the systemincorporating a device of the present invention;

[0054]FIGS. 2A and 2B show, in detail, a section through the inlet- andoutlet ports, respectively;

[0055]FIGS. 3a to 3 d show the steps involved in using in an apparatusaccording to the present invention;

[0056]FIGS. 4a-4 c show a second embodiment of the apparatus;

[0057]FIG. 5 shows an adapted inlet port, for use in a second embodimentof the present invention.

[0058] Although the system of the present invention has been describedabove in relation to Autologous Blood Transfusion, because it isparticularly advantageous in such applications, it can, of course, alsobe used in a standard wound drainage application.

[0059] A first embodiment of the invention will now be described, withreference to FIGS. 1 and 2.

[0060]FIG. 1 shows the components of an autologous blood transfusionsystem in corporating the collection flask arrangement of the presentinvention.

[0061]FIGS. 2a and 2 b show in more detail the inlet and outlet parts.

[0062] The collection apparatus of the present invention comprises acollection chamber 1 having a compressible, pleated body 2 forming abellows-type structure. An input port 3 is provided at one end of thecollection device. Two output ports 4, 5 are provided at the other end.

[0063] Between the input port 3 and the main body 2, is provided a grip6 having a thumb hole 7. The grip 6 is shaped so that the user's thumbcan be easily inserted into the thumb hole and the fingers can bearranged between the two output ports 4 and 5, when the bellows are tobe compressed on priming the chamber. This design makes the bellowsparticularly easy to prime using only one hand.

[0064] A filter is provided inside the inlet port 3. Filters may also beprovided in the outlet ports 4 and S.

[0065] The inlet side of the input port 3 is provided with one half of apush fit connection, to which a patient line 8 can be attached, by meansof the other part of the push fit connection provided on the end of thepatient line.

[0066] A simple clamp 9 can be provided on the patient line 8, which canbe closed, by the user, to close the patient line and cut off flow alongthe line.

[0067] The two output ports 4, 5, are identical. Each is provided with aclosure 10, 11 adapted to be push fit into the outlet end of the outputport. The closures 10, 11 are preferably attached by a thin plasticstrip, to the outlet port itself. Clamps 9 are also provided on the twooutput ports, again to close the ports, if required.

[0068] Blood collection bags 12, 13, of a known type, are provided to beattached to each of the outlet ports, by means of a matching push fitconnector. The connectors are also provided with closures 14, 15,similar to closures 10, 11, for closing the inlet ports to the bags, anda clamp is provided on each inlet port, to stop flow through the port. Aone-way valve may be provided at the inlet ports to the bags to preventflow-back of blood.

[0069] Each bag also has an outlet port 16, 17, provided with closuremeans.

[0070] An identification tag 18 is secured to the flask, foridentification purposes.

[0071] The method of use of the apparatus will now be described, withreference to FIGS. 3a-d.

[0072] First, the person preparing the apparatus for use, or otheroperating room personnel must ensure that the wound is completely cleanand free from any contaminates or other contraindicative substances suchas a Betadine. The components of the blood collection apparatus areprovided in a sterile package, which must be opened using asepticprocedures.

[0073] The drain tubes are placed in situ. The trocar is cut off fromeach of the drains and catheters are connected to the inlet tubing via auniversal Y connector which should be cut to fit the size of drain beingused.

[0074] The patient line 8 is clamped off using clamp 9.

[0075] The bellows 2 is then primed by being completely compressed andheld. Still holding the bellows compressed, the clamps 9 on the outletports 4, 5 are closed.

[0076] Then, a blood transfusion bag is attached to each of the outletports, using the push fit connectors.

[0077] Preferably, all of the clamps should remain closed for 20 minutesafter, e.g., the tourniquet on the patient has been released or thewound has been closed.

[0078] The patient data, including patient's name, identity number andtime should be noted on the tag 18 and also on the bags 12, 13.

[0079] The apparatus is then primed for use.

[0080] The device is then hung in an operating position, for exampleusing the bed rail strap. The device should hang below the level of thepatient, to draw the blood from the patient.

[0081] The bags are attached to the ports in a tightly rolled up state.At this time, the first transfusion bag is now unrolled.

[0082] At the appropriate time (e.g. 20 minutes after the tourniquet isreleased or the wound closed), blood collection begins. This time shouldbe noted on the collection bag. As mentioned above, the maximumpermissible collection time for anyone bag is 6 hours, or sooner if 600ml of blood is collected (i.e. the bag is filled to its maximumcapacity).

[0083] At the appropriate time, the clamps 9 on the patient line and theoutput port are opened and blood drainage begins, as the vacuum createdfrom priming the bellows 2 draws blood along the patient line 8.

[0084] A regular check should be carried out to ensure that the bellowscontinues to create a vacuum and to check the volume of blood that hasbeen collected in the transfusion bag. There may be a need to re-primethe bellows, which can be done by compressing the bellows, although inmost cases this is not necessary.

[0085] At the end of the 6 hour period, or when the bag is full, theclamp on the output port is closed, the bag is removed and the closureson the output port and the bag are sealed. The bag is then ready forinfusion, normally carried out on the ward.

[0086] Should the patient continue to bleed, the second bag 13 isunrolled, the clamp opened and the blood collected in the bag.

[0087] Should the patient continue to bleed further, beyond two 6 hourperiods or two full collection bags, a wound drainage bag can beconnected to one of the output ports, although this third collection bagmay be contaminated from the already-used port and, therefore, must onlybe used for drainage and must not be used for retransfusion.

[0088] For reinfusion of the blood collected from the patient, the clampto the inlet port of the bag is closed. The transfusion bag is thendetached from the bellows and the closure closed, if the retransfusionis to take place during collection.

[0089] The transfusion bag is then turned upside down so that the outletport is at the top. The outlet closure is opened and a filter isinserted. The blood can then be reinfused into the patient via a patientreinfusion line.

[0090] In the embodiments shown in FIGS. 1 to 3, the inlet and outletports of the bellows device are provided with simple bung type closuresthat push-fit into the respective ports.

[0091] This bung may be made of PVC. However, there can be a problem inthat after sterilisation, the PVC could release plasticisors which cancompromise the force fit. Furthermore, if small moulding flaws exist inthe bung, the stress produced by the push-fit can cause these flaws tosplit. Another problem with a simple bung and port push-fit arrangementis that, over time, air leaks can be caused between the bung and theport, causing a reduction in vacuum. The air leaks may also arise due toinaccuracies in moulding the bung.

[0092] In a preferred embodiment of the present invention, an improvedcap or closure design is provided which overcomes these problems.

[0093] This improved design is shown in FIGS. 4a to 4 c.

[0094]FIG. 4a shows a schematic view of the blood collection apparatuscomprising the new closure arrangement. FIG. 4c is a cross-sectionthrough the closure and port arrangement at the inlet port of thebellows device. FIG. 4b is a cross-sectional view of the bellowsshowing, in cross section, the input and output ports.

[0095] The main features of the improved cap design are that an O-ringis provided to ensure a secure seal between the cap and the bellowsport. This is compressed and held in place between the cap and theport's top surface. This top surface is free from any split or flashcaused by moulding, as it forms part of the shut-off between the mouldand the parison material.

[0096] With this modified closure, the port itself is also slightlymodified in that it is provided with a tapered ring located at its tip.This section fits up within the cap and fits into the inner cap profile.

[0097] The cap can then be modified such that is houses all of theexisting parts such as the line connector and the valves discussedpreviously. The profile of the cap is adapted to fit into the bore ofthe bellows port without over-stressing the port.

[0098] The main seal is provided between the cap, the O-ring and thebellows port. The cap snaps over the bellows port to give a strong andsecure mechanical fit which overcomes any migration of plasticisors,even when PVC is used.

[0099] As mentioned above, generally, in bellows type arrangements,where the vacuum is provided by the bellows themselves, the vacuum isnot constant. Therefore, such systems can only be used in post-operativeblood drainage.

[0100] In a further embodiment of the invention, the inlet port to thebellows may be specially adapted to make the apparatus suitable also forintra-operative blood drainage.

[0101] The components of the inlet port of this embodiment are shown inFIG. 5.

[0102] In this embodiment, the inlet port is adapted to have two ports,the first being a port to the patient line, as described above. Thesecond is a port having a line adapted to be attached to a vacuumsupply, e.g. a wall-mounted vacuum system, which ensures a constantvacuum through the system.

[0103] This second aspect may be combined with a ‘two outlet port’collection device as described in relation to the first aspect of theinvention, to allow the bellows type arrangement to be usedintra-operatively as well as post-operatively, by insuring a constantvacuum.

[0104] The inlet arrangement of the second aspect of the invention is,however, also useful for other bellows type wound drainage or bloodtransfer devices, where a constant vacuum is required e.g. forintra-operative use, rather than the non-constant vacuum normallyprovided by the bellows devices.

[0105] The invention thus provides a simple, user-friendly, sterileblood collection system in which the collection of blood is optimised.Another advantage is that as the first bag is filled, the assembly tiltsslightly due to the weight of the blood, and this has the effect offunnelling blood into the port. Once replaced, the same occurs with thesecond bag and so all blood is effectively collected.

1. A blood collection apparatus, comprising a collection vessel having apleated, compressible body, the vessel having an inlet port adapted tobe connected to a patient line for drawing blood from a patient; twooutlet ports, each outlet port adapted to be connected to a bloodcollection bag.
 2. A blood collection apparatus as claimed in claim 1,wherein the input and output ports are adapted to be connected to thepatient line and the bags, respectively, by means of a push fitconnection.
 3. A blood collection apparatus as claimed in claim 1 or 2,provided with closure means to optionally prevent flow through theports.
 4. A blood collection apparatus as claimed in any precedingclaim, further comprising a one-way valve at or before the inlet portand at or connected, in use, to the outlet ports to prevent flow-back ofthe blood.
 5. A blood collection apparatus as claimed in any precedingclaim, where the inlet port comprises two port connections, the firstadapted to be connected to a patient line through which blood iscollected from the patient, and the second being adapted to be attachedto a constant vacuum.
 6. A blood collection apparatus comprising a bloodcollection vessel having a pleated, compressible body, an inlet port andan outlet port; where the inlet port comprises two port connections, thefirst adapted to be connected to a patient line through which blood iscollected from the patient, and the second being adapted to be attachedto a constant vacuum.